Build it Right and Achieve Regulatory Compliance

When you make high-stakes products, you need to know your teams are adhering to quality and regulatory processes.

Jama Software lets teams focus on making innovative medical devices that drive value and improve quality of life. With Jama Connect™ configured to your workflows and best practices, teams spend more time developing products and less time caught up in quality and regulatory processes and documentation.

Jama Connect, combined with your organization’s quality process, can facilitate compliance with 21CFR820, 21CFR11, ISO 13485, ISO 14971, IEC 62304 and IEC 61508.

Review and approve robust, contextual information across stakeholders, engineers and partners.

Conduct reviews and approvals

Maintain the chain of approval and increase stakeholder participation. Within Jama Connect, tie electronic signatures to specific reviews or baselines, this combined with your organization’s quality process, can help achieve compliance with 21 CFR Part 11.

Verification and validation

Seamlessly manage V-model traceability including the test cases you use for verification and validation. With Jama Connect, alongside your organization’s quality process, you can also provide evidence to comply with government regulations and standards such as 21 CFR Part 820.

Maintain audit trails with reports

Customizable, real-time reporting and baselining allows you to track all changes to information within the system, including timestamps and associated users.

Mitigate Risk, Increase Efficiency and Drive Alignment With Traceability

The rise of software-driven medical devices and the Internet of Things has made development more complex. Innovating while ensuring quality grows more difficult all the time.

With outdated process such as manual traceability, risks only increase. Jama Connect counteracts risk with intuitive, end-to-end linking — including all related changes, decisions and people — from upstream market and product requirements to test cases and defect tracking.

Construct intuitive rules for traceability.

Quickly see the impact of change

Fine-grained impact analysis provides instant data insight. Use it to make informed decisions as requirements evolve during long development cycles or due to shifts in technology.

Manage risk analysis

Create a customizable view with calculated fields to manage your risk analysis process within Jama Connect. Ensure that your product is safe and meets regulatory standards.

Improve visibility

Combine Jama Analyze™ with Jama Connect’s powerful ability to help teams avoid the kinds of potential defects that can cause rework and missed targets. Quickly configure clean, clear dashboards to view patterns of risk across projects and time.

Reduce rework

Avoid expensive rework in the product development process by trending requirement additions, updates and deletions in Jama Analyze across each Jama Connect project, as well as other technologies important to your development process.

Evaluate quality risks

Jama Analyze enables you to evaluate potential quality risks by looking at the percentage of items in Jama Connect that are missing coverage across your relationship model. Identify critical opportunities to adjust process and improve outcomes by trending and combining the data sourced by your teams and the technologies you use most.

See it in Action

This five-minute overview illustrates how to use Jama Connect to build a complex medical device that contains both hardware and software components. Activate your free, 30-day trial.

Try Jama Connect